Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
Department of Internal Medicine, School of Community Medicine, University of Oklahoma, Tulsa, OK, USA.
J Osteopath Med. 2023 Feb 27;123(6):301-308. doi: 10.1515/jom-2022-0223. eCollection 2023 Jun 1.
In recent years, patient-centered healthcare has become a primary concern for researchers and healthcare professionals. When included in randomized controlled trials (RCTs), patient-reported outcome (PRO) measures serve a critical role in supplementing efficacy outcomes with a patient perspective.
The goals of this study are to evaluate the reporting completeness of PROs within literature concerning carpal tunnel syndrome (CTS) utilizing the Consolidated Standards of Reporting Trials Patient-Reported Outcomes (CONSORT-PRO) extension.
We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for published RCTs relating to CTS with at least one PRO measure from 2006 to 2020. Two investigators screened all RCTs for inclusion utilizing Rayyan (https://rayyan.qcri.org/), a systematic review screening platform. In an independent, masked fashion, investigators then evaluated all RCTs utilizing the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias (RoB) 2.0 tool. Bivariate regression analyses were utilized to assess relationships between trial characteristics and completeness of reporting.
Our search returned 374 publications, yet only 31 unique RCTs met the inclusion criteria. The mean overall percent of adherence for CONSORT-PRO was 41%. Our secondary outcome-assessing study characteristics-indicated significantly higher completeness of reporting in the absence of a conflict of interest statement (p<0.05), 'some concerns' for bias (p<0.005), and when journals required the use of the CONSORT statement (p<0.005). The RoB assessment determined overall suspicion for bias among included RCTs, with 35% (n=11/31) being labeled as 'high,' 58% (n=18/31) as 'some concerns,' and 7% (n=2/31) as 'low.'
Our study indicated that the completeness of CONSORT-PRO reporting was deficient within CTS trials. Because of the importance placed on PROs in clinical practice, we recommend adherence to CONSORT-PRO prior to publication of RCTs to increase the understanding of various interventions on patients' quality of life (QoL).
近年来，以患者为中心的医疗保健已成为研究人员和医疗保健专业人员关注的主要问题。当包含在随机对照试验 (RCT) 中时，患者报告的结局 (PRO) 测量通过从患者角度补充疗效结局来发挥关键作用。
本研究的目的是使用 CONSORT-PRO 扩展版评估有关腕管综合征 (CTS) 的文献中 PRO 的报告完整性。
我们检索了 MEDLINE、Embase 和 Cochrane 对照试验中心注册库 (CENTRAL) 中 2006 年至 2020 年发表的涉及 CTS 并至少有一项 PRO 测量的 RCT。两位研究者使用 Rayyan（https://rayyan.qcri.org/）这一系统审查筛选平台筛选所有 RCT。研究者以独立、盲法的方式，使用 CONSORT-PRO 改编版和 Cochrane 协作风险偏倚 (RoB) 2.0 工具评估所有 RCT。使用双变量回归分析评估试验特征与报告完整性之间的关系。
我们的搜索返回了 374 篇文献，但只有 31 项独特的 RCT 符合纳入标准。CONSORT-PRO 的平均总体依从率为 41%。我们的次要结果——评估研究特征——表明在不存在利益冲突声明的情况下，报告的完整性显著更高（p<0.05），“有些关注”偏倚（p<0.005），以及期刊要求使用 CONSORT 声明时（p<0.005）。RoB 评估确定了纳入 RCT 中的总体偏倚怀疑，其中 35%（n=11/31）为“高”，58%（n=18/31）为“有些关注”，7%（n=2/31）为“低”。
我们的研究表明，CTS 试验中 CONSORT-PRO 报告的完整性不足。由于 PRO 在临床实践中的重要性，我们建议在发表 RCT 之前遵守 CONSORT-PRO，以提高对各种干预措施对患者生活质量 (QoL) 的理解。
